Job Description:
As a Validation Engineer, you are responsible for generating development/validation protocols and reports, compiling data packs and analyzing data for adherence to established acceptance criteria. Typical processes being developed/validated include visual inspection, defect set creation and evaluation. Studies supporting these processes include understanding of defect criteria, stability and extractables/leachable.
Experience Requirements:
- Visual Inspection process validation
- Formulation process validation
- Filling process validation
- Recent hands on experience executing process validations
- For Visual Inspection, significant experience from production or engineering assignments to have in-depth knowledge of vial and/or syringe filling and inspection equipment sufficient to identify process CPP's and generate detailed validation protocol requirements and execution
- For formulation demonstrated experience with mixing and filtration process validation.
- Visual Inspection in a Pharmaceutical Experience (Pharma Experience only)
Skills
- Skills, MS Office, Geode, LIMs, Pharmaceutical Validation, Bio Pharma Validation, Validation execution,
- Technical writing abilities and good time management. Strong root cause analysis skills with cGMP experience. To be able to establish working relationships with other support and production areas in order to gather all of the necessary information required.
- Must be proficient in Geode with a working knowledge of templates, workflows and approval process
- Proficient in MS Word, Excel, PowerPoint and Outlook
- Interact well with a diverse group of individuals
- Self-motivated and willing to be proactive in resolving issues
- Excellent Verbal and written communication skills. Ability to work in a team environment.
Education: BS/MS in Engineering, Life Science or Physical Science
The hourly range for roles of this nature are $50.00 to $70.00/hr. Rates are heavily dependent on skills, experience, location, and industry.